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FDA 510(k)

3DOSE 1ml Syringe

K-Number: K250733 · 2025-07-03

ApplicantBimed Teknik Aletler Sanayi & Ticaret A.S.
Decision Date2025-07-03
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

3DOSE 1ml Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Bimed Teknik Aletler Sanayi & Ticaret A.S.. It received FDA 510(k) clearance on 2025-07-03 under 510(k) number K250733. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3DOSE 1ml Syringe?

3DOSE 1ml Syringe is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Bimed Teknik Aletler Sanayi & Ticaret A.S.. The 510(k) number is K250733.

When did 3DOSE 1ml Syringe receive FDA 510(k) clearance?

3DOSE 1ml Syringe received FDA 510(k) clearance on 2025-07-03, under 510(k) number K250733.

Who is the listed applicant for 3DOSE 1ml Syringe?

The FDA 510(k) record lists Bimed Teknik Aletler Sanayi & Ticaret A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3DOSE 1ml Syringe?

The FDA product code for 3DOSE 1ml Syringe is FMF.

Related Devices (Code: FMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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